AI drafting and QC in Microsoft Word
EU Package Leaflet
The patient leaflet has to say what the SmPC says, in words patients can follow. PharmAssist drafts each leaflet section from the matching SmPC section and keeps the link visible.
See Package leaflet (PIL) drafted in Word
A short demo on a fictitious study and product. In a live demo we walk through the same workflow and answer your questions about sources, review and deployment.
Read the transcript
A patient leaflet has to say what the SmPC says, in words patients can follow. PharmAssist works inside Word. Choose the document type and add your source files. It lays out the document's outline, right in Word. Pick a section, and PharmAssist drafts it from your sources. Review the draft, then insert it into your document. You can also ask questions in chat. Answers come from your own files, and show which ones they used. From your sources to a draft in Word, ready for expert review. Book a demo at gentext.ai/pharma.
Can AI write a patient information leaflet from an SmPC?
Yes, as a draft for expert review. PharmAssist maps each leaflet section to the SmPC section it must reflect, for example section 4 Possible side effects from SmPC 4.8, and drafts it in plain language with a citation to the source. Your team checks the wording, runs readability testing as required and approves it.
How this document gets written today
Writing a package leaflet means translating technical SmPC content into plain language without changing its meaning. Frequencies, warnings and dosing instructions all have to match the SmPC exactly while reading naturally for a patient.
Every SmPC update triggers a leaflet update, and reviewers have to check each plain-language sentence back to the technical source.
What your team can work on
Structure follows the EMA QRD package leaflet template; readability testing follows your existing process.
Plain-language section drafts
Draft leaflet sections such as 3 How to take and 4 Possible side effects in patient language, grouped by frequency where the template requires it.
SmPC-to-leaflet citations
Each statement cites the SmPC section it reflects, so reviewers can confirm the meaning is unchanged.
Template headings
Drafts follow the QRD package leaflet headings and the standard statements your template includes.
Change follow-through
When the SmPC changes, redraft only the affected leaflet sections from the new text.
How it works for Package leaflet (PIL)
Choose package leaflet
Select EU Package Leaflet and the sections in scope.
Add the SmPC
Upload the approved SmPC. Leaflet sections map to the SmPC sections they must reflect.
Draft and check
Draft in patient language and review the citations and checks.
Insert and test
Insert into Word, then continue to readability testing and approval in your usual process.
What it drafts from
Select the approved sources for the task. Data handling follows the deployment and model-service configuration agreed with your team.
- Approved SmPC
- QRD package leaflet template
- Previous leaflet and user-testing notes
- House plain-language style
What stays with your team
PharmAssist supports your document workflow. Interpretation, medical and regulatory judgement, approval and submission stay exactly where they are today, with qualified people and your existing review chain.
Choose GenText-hosted SaaS or a private deployment. Confirm access, data handling, model services and retention during supplier qualification.
Security and deployment detailQuestions we are asked about this document
Does it replace readability (user) testing?
No. PharmAssist helps produce a clearer first draft and keeps it tied to the SmPC. User testing and approval stay with your team.
How does it keep the leaflet consistent with the SmPC?
Each leaflet section is drafted from the SmPC section it must reflect, and every statement carries a citation to that section.
Can it handle side-effect frequency groupings?
Yes. Side effects are drafted from SmPC 4.8 and grouped using the frequency categories in your template, with the source cited.
Who reviews and approves the Package leaflet (PIL)?
Your qualified specialists do. PharmAssist drafts and checks; scientific interpretation, medical and regulatory judgement, quality review and approval stay with your team and your existing review chain. Open questions and missing inputs stay visible in the draft until a person resolves them.
Does PharmAssist work inside Microsoft Word?
Yes. PharmAssist is a Microsoft Word add-in for Windows, Mac and Word on the web. You choose the document type, add your source files, review the outline and section drafts in a side pane, and insert approved text into the document you are already working on.
Where does our data go, and do we need a Veeva connection to begin?
Choose GenText-hosted SaaS or a private deployment. Data handling, model services and retention are confirmed with your technical owner during supplier qualification. A demonstration starts with fictitious documents and upload; connections to Veeva Vault or other source systems are scoped during implementation.
Teams that start here often widen to
Regulatory labelling
EU Summary of Product Characteristics
Draft QRD-structured SmPC sections from your core data sheet.
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Regulatory labelling
Local and Country Labels
Adapt core labelling to one country’s rules and approved wording.
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Scientific communications
Plain Language Summaries
Tell patients and the public what a study found, simply.
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Talk to us about Package leaflet (PIL)
Tell us your role, source material and next document milestone. We will confirm the demonstration scope and define a paid pilot with your team.
Prefer email? alex@gentext.ai